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OpenTrials
Completed

NCT Number: NCT07841444

Laparoscopic vs Open Appendectomy

his randomized controlled trial was conducted to compare the frequency of superficial surgical site infections (SSIs) following laparoscopic appendectomy and open appendectomy in patients undergoing surgical treatment for acute appendicitis. The study was carried out in the Department of Surgery, Bahawal Victoria Hospital, Bahawalpur, over a period of six months from 24 January 2026 to 23 July 2026. A total of 276 patients were included in the study, with 138 participants allocated to each treatment group. Patients enrolled in the trial were assigned to one of two study groups according to the study protocol. Group A underwent laparoscopic appendectomy, while Group B underwent open appendectomy. The purpose of the comparison was to determine whether the operative approach was associated with a difference in the occurrence of superficial surgical site infection after appendectomy. The study therefore evaluated two established surgical approaches for the same clinical condition while maintaining a randomized comparative design.

The primary outcome of the study was the frequency of superficial surgical site infection after appendectomy. Superficial surgical site infection refers to infection involving the skin and subcutaneous tissue at the surgical incision. The occurrence of this postoperative complication was assessed in participants in both groups using the same outcome definition and follow-up approach specified in the study protocol. The frequency of superficial SSI was then compared between the laparoscopic and open appendectomy groups.

The study was designed as an interventional randomized controlled trial. Participants were assigned to an intervention group on the basis of the study protocol rather than simply being observed according to the treatment they would otherwise have received. The intervention under investigation was the operative approach: laparoscopic appendectomy versus open appendectomy. No investigational drug or biologic product was evaluated, and the study was not conducted under a U.S. Food and Drug Administration Investigational New Drug application. Likewise, the study did not investigate a U.S. FDA-regulated device as the intervention and was not conducted under an Investigational Device Exemption.

The study population consisted of patients undergoing appendectomy at the Department of Surgery, Bahawal Victoria Hospital, Bahawalpur. Eligible participants were enrolled according to the predefined inclusion and exclusion criteria of the study protocol. Participants in the laparoscopic group received appendectomy through the laparoscopic approach, whereas participants in the open group received appendectomy through the conventional open approach. Perioperative care and postoperative assessment were conducted according to the institutional surgical protocol and the requirements of the study. Data were collected prospectively during the study period and were used to assess the postoperative outcome of interest. The incidence of superficial surgical site infection was recorded for participants in each treatment group. The results were subsequently compared between the two groups to determine the observed difference in the frequency of superficial SSI following laparoscopic versus open appendectomy. The analysis was based on the predefined study outcome and the randomized allocation of participants.

The trial was conducted in a hospital surgical setting and included a total sample of 276 participants, providing 138 participants in each group. The study was intended to generate comparative clinical evidence regarding superficial wound infection after the two operative approaches. By directly comparing laparoscopic and open appendectomy within a randomized controlled trial, the study provides a structured assessment of the postoperative wound-related outcome in the enrolled patient population.

The study was undertaken after institutional ethical oversight and approval in accordance with the applicable requirements. Written informed consent was obtained from participants before enrollment, as specified in the study protocol. Participant information was handled confidentially, and study procedures were conducted in accordance with the approved protocol and institutional requirements.

The trial compares superficial surgical site infection between patients undergoing laparoscopic and open appendectomy at the study center. Its focus is the wound outcome associated with the two surgical approaches

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Key information

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery

Bahawalpur, Punjab Province, 63100, Pakistan

About this study

Acute appendicitis is one of the most common surgical emergencies and appendectomy remains one of the most frequently performed emergency abdominal surgical procedures. Open appendectomy has traditionally been used as the standard operative approach, while laparoscopic appendectomy has increasingly been adopted because of its minimally invasive nature and potential postoperative advantages. Surgical site infection is an important postoperative complication of appendectomy because it can cause additional morbidity, delay wound healing and recovery, increase the need for postoperative treatment and follow-up, and potentially prolong healthcare utilization. The frequency of surgical site infection may vary according to the operative approach, patient characteristics, disease severity, operative technique, and perioperative management.

The present randomized controlled trial was conducted to compare the frequency of superficial surgical site infections following laparoscopic appendectomy and open appendectomy in patients presenting with acute appendicitis. The study was conducted in the Department of Surgery, Bahawal Victoria Hospital, Bahawalpur, over six months, from 24 January 2026 to 23 July 2026. A total of 276 patients were included, with 138 participants allocated to each group.

The study population consisted of patients aged 15 to 60 years of either sex who presented with acute appendicitis and fulfilled the predefined eligibility criteria. Acute appendicitis was diagnosed on the basis of right iliac fossa pain with a visual analogue scale score of 3-10, positive rebound tenderness on clinical examination, and a white blood cell count greater than 10,000/mm³. Patients were eligible if the duration of symptoms was 48 hours or less. Both elective and emergency appendectomies were included.

Patients were excluded if they had generalized peritonitis, perforated appendicitis, uncontrolled diabetes mellitus, immunosuppression, previous abdominal surgery, chronic renal failure with serum creatinine above 1.5 mg/dL, or chronic liver disease with serum bilirubin above 2 mg/dL.

After approval of the study synopsis and institutional ethical approval, eligible patients were enrolled after obtaining informed written consent. Baseline demographic and clinical information was recorded using a structured data collection proforma. Variables included age, sex, duration of symptoms, height, weight, body mass index, obesity status, residence, type of surgery, socioeconomic status, diabetes mellitus, and duration of surgery.

A body mass index greater than 27 kg/m² was considered obese and 27 kg/m² or below was considered non-obese. Residence was categorized as urban or rural according to documented residential address. Socioeconomic status was categorized according to monthly household income into poor class (≤20,000 PKR), middle class (21,000-40,000 PKR), and upper class (≥41,000 PKR). Diabetes mellitus was recorded on the basis of a known history of diabetes with ongoing treatment and controlled fasting blood glucose below 126 mg/dL on two consecutive measurements.

Participants were randomly allocated in a 1:1 ratio using a lottery method. Group A underwent laparoscopic appendectomy, while Group B underwent open appendectomy. All participants received prophylactic antibiotics according to the study protocol, and the duration of postoperative intravenous and outpatient antibiotic therapy was recorded. All operations were performed by the same consultant surgeon with at least five years of post-fellowship experience to maintain consistency in operative technique.

Patients were followed for seven postoperative days. During follow-up, the surgical wound was assessed for superficial surgical site infection and findings were recorded on the structured proforma. The primary outcome was the frequency of superficial surgical site infection within seven postoperative days. Superficial SSI was defined according to the predefined clinical criteria. A patient was considered to have superficial SSI if purulent wound discharge, redness around the wound or stitches, or postoperative fever exceeding 100°F was observed within seven days following surgery. The outcome was recorded as present or absent.

Demographic and clinical characteristics were recorded for comparison between groups. These included age, sex, duration of symptoms, BMI and obesity status, residence, type of surgery, socioeconomic status, diabetes mellitus, and duration of surgery. Stratified analysis of superficial SSI was planned according to these characteristics.

The sample size was calculated using a 5% level of significance and 80% power, based on an anticipated superficial surgical site infection rate of 20% following laparoscopic appendectomy and 35% following open appendectomy. A total of 276 participants were included, with 138 in each group. Consecutive sampling was used for participant enrollment, followed by random allocation using the lottery method.

Operative duration was recorded for each participant and categorized into short and long duration according to the predefined study categorization for stratified analysis.

Statistical analysis was performed using SPSS version 25.0. Continuous variables were assessed for normality using the Shapiro-Wilk test. Normally distributed continuous variables were expressed as mean ± standard deviation, while non-normally distributed variables were presented as median with interquartile range. Categorical variables were summarized using frequencies and percentages. The independent-samples t-test was used for normally distributed continuous variables, while the Mann-Whitney U test was used for non-normally distributed variables. Categorical variables were compared using the Chi-square test or Fisher's exact test, as appropriate.

The primary outcome was compared between the laparoscopic and open appendectomy groups using the Chi-square test. Stratified analyses were performed according to age group, sex, duration of symptoms, BMI category, residence, type of surgery, socioeconomic status, diabetes mellitus, and duration of surgery. A p-value of ≤0.05 was considered statistically significant.

The study specifically focused on superficial SSI occurring during the first seven postoperative days and did not combine superficial infection with deep or organ/space surgical site infection. The study was conducted after institutional ethical approval and approval of the study synopsis. Written informed consent was obtained from all participants before enrollment. Participant demographic and clinical information was recorded using a structured proforma, and postoperative wound findings were documented during the seven-day follow-up period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 15-60 years of either sex.
  • Patients diagnosed with acute appendicitis according to the predefined operational definition and undergoing appendectomy.
  • Duration of symptoms less than 48 hours.
  • Both elective and emergency appendectomy cases.

Exclusion criteria

  • Patients with generalized peritonitis or perforated appendicitis.
  • Patients with significant comorbidities, including uncontrolled diabetes mellitus or immunosuppression.
  • Patients with a history of previous abdominal surgery.
  • Patients with chronic renal failure, assessed on history and medical records, with serum creatinine >1.5 mg/dL.
  • Patients with chronic liver disease, assessed on history and medical records, with serum bilirubin >2 mg/dL.

Treatment and study plan

laparoscopic appendectomy

Procedure

Laparoscopic appendectomy was performed for acute appendicitis in 138 randomized participants. The procedure was carried out by the same consultant surgeon with at least 5 years of post-fellowship experience. Prophylactic antibiotics were administered according to the study protocol. Participants were followed for 7 postoperative days to assess superficial surgical site infection.

open appendectomy

Procedure

Open appendectomy was performed for acute appendicitis in 138 randomized participants. The procedure was carried out by the same consultant surgeon with at least 5 years of post-fellowship experience. Prophylactic antibiotics were administered according to the study protocol. Participants were followed for 7 postoperative days to assess superficial surgical site infection.

Primary outcomes

  1. Frequency of superficial surgical site infection (SSI) following laparoscopic versus open appendectomy

    Time frame: Within 7 postoperative days after appendectomy.

    The primary outcome is the occurrence of superficial surgical site infection within 7 postoperative days after appendectomy. SSI will be recorded as present if the patient develops purulent wound discharge, redness around the wound or stitches, or postoperative fever greater than 100°F during the follow-up period. The frequency of superficial SSI will be compared between the laparoscopic appendectomy and open appendectomy groups.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Quaid-e-Azam Medical College

Other

Registry information

Official study title

Comparison of the Frequency of Superficial Surgical Site Infections Between Laparoscopic Versus Open Appendectomy

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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